MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; SYRINGE BARREL

Catalog Number 802010

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

Insufficient information provided in medwatch report, trend analysis shows no abnormalities.Scenario described in the report likely concludes that the reporters distributor is creating kits from the et syringes and et safety syringes.

Event Description

Received medwatch report # mw5150607 on 01/22/2024 by an unknown reporter regarding mhc items 802010 lot 64031.Reported to medwatch on 01/24/2024.Medwatch report states "tour insulin syringes went on back order.Easy touch u-100 insulin syringe barrels, 1ml syringes.We had also ordered easy touch syringe barrels, 1ml syringes.I have included pictures of the products.We put a 1cc syringe in with insulin instead of the 100 unit syringe.There was no error, the insulin was given correctly.(b)(4).Reference report: mw5150607.".

• Brand Name: EASYTOUCH
• Type of Device: SYRINGE BARREL
• Manufacturer (Section D): BERPU MEDICAL TECHNOLOGY CO., LTD; no.14 xingji road; yongxing street; wenzhou city, longwan 32500 0; CH 325000
• Manufacturer (Section G): BERPU MEDICAL TECHNOLOGY CO., LTD; no.14 xingji road; yongxing street; wenzhou city, longwan 32500 0; CH 325000
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 18646847
• MDR Text Key: 336057150
• Report Number: 3005798905-2024-03163
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 802010
• Device Lot Number: 64031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1